Dynavax Technologies Corp said its experimental hepatitis B vaccine was found to be safe and effective in a late-stage study, paving the way for the company to resubmit its marketing application. The earlier marketing application for the vaccine, HEPLISAV-B, was rejected in February 2013 by the U.S. Food and Drug Administration (FDA), which sought additional safety data. California-based Dynavax said it plans to resubmit the marketing application by the end of March and anticipates a six-month review by the FDA.
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Dynavax to resubmit hep B vaccine for approval after positive data